Kornimate/medical-research-clean huggingface dataset:
a trial to evaluate the improvement in lung cancer patients receiving radiation with or without brachytherapy

Conditions: Non-small Cell Lung Cancer

Summary: a trial to improve the quality of life of patients with advanced non-small cell lung cancer (nsclc) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

in patients with advanced nsclc to compare the added benefit of high dose rate intraluminal brachytherapy (hdrib) with external beam radiation (ebr). benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.

Eligibility criteria:
inclusion criteria: * cytologic or histologic proof of non-small cell lung cancer (nsclc) * stages iii, iv or recurrent disease * documented endobronchial luminal disease by either endoscopy or ct-imaging * candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis exclusion criteria: * age less than 18 years of age * uncontrolled or symptomatic brain metastases * anticipated survival of less than 3 months * systemic therapy planned to begin within 6 weeks following randomization * systemic therapy within 4 weeks of planned study randomization * any prior radiotherapy involving the lungs * cardiac arrest or myocardial infarction within 6 months prior to study randomization * inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (copd), bleeding disorders, or other medical conditions which will preclude the use of hdrib * pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women * unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline qol assessments required for the trial * having received an investigational agent within one month of study randomization * inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility

Keywords: brachytherapy external beam radiation high dose rate intraluminal brachytherapy lung cancer quality of life radiation treatment bronchus
pharmacology study of aerosolized liposomal 9-nitro-20 (s)-camptothecin (l9nc)

Conditions: Corpus Uteri; Endometrial Cancer

Summary: the purpose of this study is to determine the amount of aerosolized liposomal-nitro-20 (s)-camptothecin (l9nc) in a patients blood and tumor.

patients on this study are being asked to allow the researchers to take a piece of some normal endometrial tissue and tumor tissue. no additional endometrial tissue will be taken for this study other than what is surgically indicated to resect the patients tumor completely. prior to this surgery, patients will receive one more dose of l9nc in the outpatient clinic in the same manner as the other l9nc treatments they have received. after the tumor has been removed, the tissue will be examined by a pathologist, who will take what is needed to diagnose the residual disease. what is not needed for patient care will be used for research. a piece of the tumor and some normal endometrial tissue surrounding the tumor will be sent to the investigational drug program laboratory, which is located in the cancer center, to measure the amount of drug that is left in the patients tumor. the patients tissue will be kept until all tissues are collected from all patients, which could take up to 10 years. the tissue will not be used for any other purpose. the samples will be labeled with the patients initials.

Eligibility criteria:
inclusion criteria: * patients participating in phase ii study of aerosolized liposomal 9-nitro-20 (s)- camptothecin (l9nc) in patients with metastatic or recurrent cancer of the endometrium are eligible. exclusion criteria: * not specified.

Keywords: endometrium tissue l9nc
tiotropium 18ug inhalation capsule using a handihaler® among korean copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among korean patients with copd. at visit 1, patients who are diagnosed as copd will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). patients' fev1 will be assessed before start of treatment (visit 1) and at the end of the 30 day treatment period (visit 2). occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.

study design:

Eligibility criteria:
inclusion criteria: older than 40 years old diagnosed as copd no previous spiriva administration no contraindication for spiriva according to the product label exclusion criteria: patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
vitamin e and male infertility

Conditions: Male Infertility

Summary: the goal of this study is to determine whether there is a correlation between the levels of vitamin e in sperm and sperm dna fragmentation. previous research has shown that damage to the dna in sperm may cause infertility or increase the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming majority of sperm). some studies suggest that dna damage can be caused by oxidative stress. antioxidants, such as vitamin e, which are present in some foods, can prevent damage to cells from "free radicals", which are naturally present by-products of metabolism. we ask whether there is a correlation between sperm dna damage and vitamin e

sperm dna damage is an emerging cause of male infertility that is likely to be more common among men with increased reactive oxygen species in the ejaculate. vitamin e can protect the sperm membrane from oxidative damage and increased levels are associated with low levels of reactive oxygen species. this is a study of vitamin e levels in the spermatozoa and sera of 48 infertile men, and 20 fertile men as a control group, to look for correlations between sperm vitamin e levels and the degree of sperm dna fragmentation. dietary intake of antioxidants will also be included.

Eligibility criteria:
inclusion criteria: * infertile men with previously abnormal semen analyses. * control group: fertile adult males exclusion criteria: * proxceed use within 3 months of the start of study. * vitamin e supplements with \> 45 iu daily

Keywords: male infertility
effect of beta-alanine on heart rate response

Conditions: Exercise; Fatigue

Summary: beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. the physical working capacity test has been used to show significant increases in physical working capacities following supplementation. the physical working capacity tests were originally developed by moritani et al. 1981 and devries et al. 1982 to measure the point of onset of muscular fatigue. it is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.

an equal number of men and women will be recruited \[men, n=20 (10 placebo \[pl\]; 10 beta-alanine (active)\]; \[women,n=20 (10 pl; 10 active)\]. men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.

Eligibility criteria:
inclusion criteria: * between the ages of 18-35 years old * be recreationally active (defined as accumulating 1-5 hours of moderate intensity exclusion criteria * any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire * must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months

Keywords: dietary supplement carnosine
study of sunobinop on alcohol consumption in alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.


Eligibility criteria:
key inclusion criteria include: * male and female age ≥18 years. * diagnosis of moderate or severe alcohol use disorder. * currently seeking treatment for alcohol use disorder. * has 4 or more heavy drinking days (hdd) in each of the 4 weeks prior to baseline visit. key exclusion criteria include: * subjects that meet current dsm-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine. other protocol-specific inclusion and exclusion criteria may apply.

Keywords: alcohol consumption moderate to severe alcohol use disorder
oscipulse d-dimer pilot trial

Conditions: Ischemic Stroke

Summary: pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the oscipulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for dvt prophylaxis in patients admitted in the neuro icu or intermediate neurological care unit with acute ischemic stroke.

this is a single site, randomized open label two arm study. the patient population will be randomly divided into two arms, with one receiving the oscipulse system and the other receiving standard intermittent compression therapy. both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge, whichever is shorter, unless clinically required to be removed. daily d-dimer levels will be assessed until day 7 or discharge. if required beyond day 7, standard compression therapy will be provided. an interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality. if indicated, enrollment will be increased up to 40.

Eligibility criteria:
inclusion criteria: 1. adult aged ≥ 18 years old 2. admitted to the neuro intensive care unit or intermediate neuro care unit with a diagnosis of ischemic stroke 3. last known normal \< 24 hours. 4. nih stroke score ≥5 5. weakness in at least one leg (≥ 1 point on the nihss lower extremity motor scores) 6. prescribed mechanical therapy for dvt prophylaxis. exclusion criteria: 1. inability or contraindication to applying ipc to both legs such as: * evidence of acute bone fracture in lower extremities * acute burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, in the lower extremities at the site of ipc placement * acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness. * amputated foot or leg on one or two sides * compartment syndrome (acute injury causing swelling and ischemic injury) * severe lower extremity edema (+4 edema as documented by clinical team) * acute deep vein thrombosis 2. subjects who received thrombolytic therapy (e.g. alteplase or tenecteplase) for their stroke 3. known pregnancy or within 6 weeks of postpartum period. 4. limitation of life support, life expectancy \< 7 days, or in hospice care 5. a head-unit is unavailable within 24 hours of last known normal. 6. at the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
bioavailability of voriconazole

Conditions: Voriconazole; Bioavailability; Critically Ill

Summary: the objective of this study is to obtain the absolute bioavailability of voriconazole in critically ill icu patients, because pharmacokinetics can be different in critically ill patients due to alterations in function of various organs and body systems compared with healthy volunteers.

the bioavailability of voriconazole, based on healthy volunteers, is estimated to be \>90%. due to the high bioavailability of voriconazole, switching between oral and intravenous administration is permitted if clinically allowed. few data are available for the bioavailability of voriconazole in critically ill patients. however, to obtain a therapeutic concentration of voriconazole (\>1.5 mg/l, which is associated with a beneficial response to treatment) one study showed that a higher oral dose is required compared with the intravenous dose, to obtain this therapeutic concentration. therefore, the pharmacokinetics can be changed in critically ill patients, including bioavailability. in this study, patients who receive voriconazole orally (prescribed by their attending physician) will receive one intravenous dose of voriconazole instead of the oral dose. the intravenous dose will be the same as the oral dose voriconazole.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 yrs; * treatment with voriconazole; * admission to an icu; * written informed consent. exclusion criteria: * blood sampling by central venous catheter or peripheral cannula not possible; * concomitantly using a strong inhibitor or inducer of cytochrome p450.
frequency of fibromyalgia syndrome in elderly patients aged 80 and above and its relationship with geriatric parameters

Conditions: Fibromyalgia; Old Age; Debility

Summary: the aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * age 80 and above * patients with complete detailed geriatric assessment parameters exclusion criteria: * presence of neurodegenerative disease (dementia, parkinsonism) * immobilized patient * those who have had an acute illness (infection, fracture, cerebrovascular disease) in the last month * having psychotic disorders * having severe hearing loss
filmarray pneumonia panel for antimicrobial treatment of hap/vap in intensive care units

Conditions: Pneumonia, Ventilator-Associated; Pneumonia, Hospital Acquired; Critically Ill

Summary: microbiologic diagnosis of pneumonia is often limited by a long turnaround time of cultures. this randomized trial aims to evaluate the impact of biofire filmarray pneumonia panel on (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics in patients treated for hospital-acquired or ventilator-associated pneumonia (hap/vap) in icu.

the study subjects are adults treated for hap/vap in icu, who should be enrolled within 24 hrs since the first administration of antibiotics. informed consent are obtained from the subjects or their legal proxies. due to the unique characteristics of icu and the current covid-19 pandemic, consent may be obtained via telephone when given by legal proxies; written consent should be obtained later. the subjects who meet the inclusion criteria are randomized into either intervention and control arms in 1:1 ratio. respiratory specimens from the subjects in the intervention arm are tested with the filmarray pneumonia panel. other routine microbiologic tests are performed for the subjects in both arms. the results are reported via electronic medical record, and the treating physicians may adjust antibiotic regimen with the assistance from the guidance formulated by the study investigators. no intervention is made on the antimicrobial treatment in the control arm. primary outcomes are (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics.

Eligibility criteria:
inclusion criteria: 1. aged 19 years or older 2. diagnosed with hospital-acquired or ventilator-associated pneumonia and being treated in an intensive care unit 3. patient or his/her legal proxy agrees to participate and is able to provide informed consent exclusion criteria: 1. has been treated with antibiotic for hap/vap for 24 hr or longer 2. requires antibiotic treatment for indications other than hap/vap 3. bacteria has been isolated from respiratory specimens within 7 days prior to screening 4. immunocompromised host whose major differential diagnosis includes pneumocystis jirovecii or cytomegalovirus pneumonia 5. expected to die within 2 days since screening due to underlying disease 6. has an advance directive against mechanical ventilation or cardiopulmonary resuscitation 7. does not want to participate or unable to provide consent 8. determined to be unfit by the study investigator
pilot study of zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer

Conditions: Lung Cancer

Summary: pilot study of zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. the purpose is to assess the effects of zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥70 years * performance status- eastern cooperative oncology group (ecog) 0-1 * histologically or cytologically confirmed lung cancer * did not receive bisphosphonate treatment exclusion criteria: * appear relapse and metastasis * receive other bisphosphonate treatment * active or uncontrolled infection * pregnant or lactating women

Keywords: aged patients
reduction in pain intensity following iv or oral pain-relieving products

Conditions: Pain

Summary: the purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity. the models evaluated were the ultraviolet-b (uvb) burn and intradermal capsaicin experimental pain models. medications compared were a single dose each, of intravenous (iv) acetaminophen, oral acetaminophen, placebo, and iv morphine.


Eligibility criteria:
inclusion criteria 1. must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations. 2. must be male, caucasian, between 18 and 55 years of age (inclusive) at the time of the screening. 3. must have a body mass index (bmi) ≥ 19.0 and ≤ 30.0 kg/m2 with a minimum weight of 110 pounds (50 kg) at screening. exclusion criteria 1. a positive test result for human immunodeficiency virus (hiv), hepatitis b (surface antigen), or hepatitis c virus antibody at screening. 2. a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen, morphine, or capsaicin or to any of the excipients in the iv or oral formulations used. 3. a positive test result for drugs of abuse, alcohol, or cotinine. 4. fitzpatrick skin type v or vi (based on a skin type score of greater than 30. 5. a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study. 6. any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.

Keywords: comparison
comparison of intubating condition of the mcgrath videolaryngoscope with and without muscle relaxant

Conditions: Muscle Relaxant

Summary: the objective of this study was to evaluate intubating condition using the mcgrath® vl series 5, with and without muscle relaxant

thirty-four patients with asa classification i-ii, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. the mcgrath® vl intubation was initiated after 90s, when the patients were fully relaxed. the primary outcome was to compare tracheal intubating conditions between two groups. the secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. statistical analyses were performed using the r program version 2.14.2. the level of statistical significance was set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * age 18-65 years old. * asa class i-ii. * elective surgery required general anesthesia with oroendotracheal intubation exclusion criteria: * suspected or known difficult airway. * patient with risk of aspiration with required of rapid sequence induction . * plan remained intubation. * allergic to drugs used in the study. * renal or hepatic disease.

Keywords: mcgrath® videolaryngoscope intubating condition muscle relaxant intubation
alcohol consumption and type 2 diabetes mellitus risk in nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease; Light-to-moderate Alcohol Consumption; Type2 Diabetes Mellitus

Summary: this study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (lmac) and risk of type 2 diabetes mellitus (t2dm) in individuals with nonalcoholic fatty liver disease (nafld).


Eligibility criteria:
inclusion criteria: 1. aged 18 years or above 2. undergoing annual health examinations in 2009 in zhenhai lianhua hospital, ningbo, china. 3. informed about the study exclusion criteria: 1. female participants; 2. missing data on ultrasound, alcohol consumption, and t2dm status; 3. alcohol consumption \> 210 g per week, and binge drinkers; 4. with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.
efficacy of different types of milk in improving sleep quality in subjects with sleep problems (milca)

Conditions: Poor Quality Sleep

Summary: randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.

the duration of the study will be 90 days (12 weeks). each day they will have to consume the product under investigation. the subjects who meet the selection criteria will be randomly distributed in each of the study groups (a, b, c or d, depending on the group in which they have been randomized). each day the subjects will have to fill in a diary on sleep quality and concomitant medication. they will make a total of two visits to the research laboratory and the tests preestablished in the protocol will be performed. subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Eligibility criteria:
inclusion criteria: * healthy adults (\> 18 years). * low sleep quality by pittsburgh sleep quality questionnaire (psqi). * volunteers able to understand the clinical study and willing to comply with the study procedures and requirements. exclusion criteria: * subjects with serious or terminal illnesses. * subjects with known allergy or hypersensitivity to any of the components of the investigational product. * participation in another study involving blood draws or dietary intervention. * subjects with body mass index above 32 kg/m2. * pregnant or lactating women. * use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs. * organic dementias such as alzheimer's, huntington's disease, parkinson's and senile dementia. * inability to understand informed consent (ic).

Keywords: ashwagandha extract tryptophan